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A PET/MRI Study of Cobenfy on Dopamine Transmission in Schizophrenia

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Re-verified, no change to tracked fieldsv4
  2. Notable Recruitment opened
    • Site details revised
    v3
  3. Notable Start date: Apr 1, 2026 to Jul 1, 2026v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a single site clinical trial in which 12 participants with schizophrenia will be randomized to one of three doses of treatment with Cobenfy for 5 weeks. \[18F\]DOPA PET scans will be obtained before and after treatment to examine the effects of Cobenfy on dopamine transmission. The overall objective of the current study is to measure Cobenfy's ability to engage its putative target (DA transmission/synthesis capacity in the striatum and midbrain as measured by \[18F\]DOPA Kicer (\[18F\]DOPA relative uptake rate)).
Trial Details
NCT Number NCT07423546
Lead Sponsor New York State Psychiatric Institute
Collaborators: Bristol-Myers Squibb
Conditions
(from sponsor)
SCHIZOPHRENIA 1 (Disorder), Schizoaffecitve Disorder
Enrollment 12 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov